Guidance Document Portal

Executive Order 13891 requires agencies to put their guidance documents on easily searchable websites so individuals are able to access them, and Department of Justice policy prohibits using guidance as a substitute for regulation. Guidance may not be used to impose new requirements on persons outside the Executive Branch except as expressly authorized by law or expressly incorporated into a contract, grant, or cooperative agreement. See JM 1-19.000.

Guidance documents are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance not so authorized or incorporated that is not accessible through this guidance portal, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department’s complete discretion, consistent with applicable laws.

Furthermore, guidance documents may not represent the Department’s authoritative or official position and generally are not intended to receive judicial deference. A guidance document may be considered the Department’s authoritative or official position only if it is issued in a form understood to reflect the Department’s authoritative policy, and only if it emanates from those Department officials whose actions in the relevant context may be said to reflect the considered views of the Department as a whole. See Question 25 of OMB Memorandum M-20-02, Guidance Implementing Executive Order 13891 (October 31, 2019).

Effective February 28, 2020, these documents can also be viewed and commented on at the United States Department of Justice Guidance Portal, the link to which will be posted soon.

In light of the current public health crisis declared by the Secretary of HHS on January 31, 2020, as a result of Coronavirus Disease 2019 (COVID-19) and the determination by WHO on March 11, 2020 that the global COVID-19 outbreak constitutes a pandemic, DEA will grant an exception to those provisions of 21 CFR 1303.24(b) that normally require the inventory for individual manufacturers to remain at 65 percent or less. Under this exception being granted today, all DEA registered bulk manufacturers are allowed to exceed the 65 percent ceiling in order to supply dosage form manufacturers with the active pharmaceutical ingredient(s); this may be necessary to manufacture specific products to avoid existing or potential shortages. This exception does not authorize any manufacturer to exceed his previously established annual manufacturing quota.

03-25-2020

03-26-2020

Other

COVID-19

No

COVID-19 Exception (5% Rule)

DEA-DC-29

Records and Reports

During the Covid-19 Public Health Emergency, DEA will temporarily permit registered practitioners such as hospitals, pharmacies, and physicians to distribute controlled substances in excess of five percent of their total number of dosage units of controlled substances distributed to other registered dispensers during this calendar year, without registering as a distributor. All DEA security, recordkeeping and other applicable regulations, including state requirements, remain in effect.

04-13-2020

04-13-2020

Other

COVID-19

No

COVID-19 Exception (Campus Registration)

DEA-DC-28

Registration - COVID-19

Due to the Covid-19 Public Health Emergency, DEA-registered hospital/clinics may utilize alternate satellite hospital/clinic locations providing temporary services under their current registrations. DEA will allow such satellite hospitals/clinics to handle controlled substances and to receive shipments of controlled substances directly from distributors. DEA must be notified by all registered hospital/clinics of any satellite locations intending to handle controlled substances.

04-11-2020

04-13-2020

Registration

COVID-19

No

COVID-19 H.D.A. Question and Responses

DEA-DC-032

COVID-19 H.D.A. Question and Responses

Due to the Covid-19 Public Health Emergency, DEA has issued guidance to Distributors to ensure regulatory compliance regarding secure delivery of controlled substance shipments to hospitals, pharmacies and NTPs, documentation and recordkeeping, due diligence requirements, and authorization for emergency alternate distribution sites.

04-10-2020

06-04-2020

Records and Reports

COVID-19

No

COVID-19 OTP Signed Delivery Exception to Regs

DEA-DC-27

Methadone

During the Covid-19 Public Health Emergency, DEA will permit distributors to deliver narcotic substances to Narcotic Treatment Programs without requiring immediate signature by the NTP’s authorized individual accepting delivery. Distributors must confirm physical possession by the NTP and complete additional recordkeeping requirements in a timely manner.

04-11-2020

04-13-2020

Other

COVID-19

No

COVID-19 Off-Site OTP Delivery Method

DEA-DC-25

Methadone

During the COVID-19 health emergency, DEA will permit OTPs to regularly use off-site locations located in the same state in which they are registered with DEA to deliver take-home doses of methadone to patients authorized to receive them, without separately registering those locations. OTPs must obtain approval for unregistered delivery locations from local DEA offices and SOTA.

04-07-2020

04-07-2020

Other

COVID-19

No

COVID-19 Office Site Delivery Buprenorphine)

DEA-DC-030

Buprenorphine

During the COVID-19 health emergency, DEA will permit OTPs to regularly use off-site locations located in the same state in which they are registered with DEA to deliver take-home doses of buprenorphine to patients authorized to receive them, without separately registering those locations. OTPs must obtain approval for unregistered delivery locations from local DEA offices and SOTA.

04-28-2020

04-29-2020

Other

COVID-19

No

COVID-19 Prescribing Chart

DEA-DC-23

Prescriptions

In response to the COVID-19 public health emergency declared by the Secretary of Health and Human Services, the Drug Enforcement Administration (DEA) has adopted policies to allow DEA-registered practitioners to prescribe controlled substances without having to interact in-person with their patients. This chart only addresses prescribing controlled substances and does not address administering or direct dispensing of controlled substances, including by narcotic treatment programs (OTPs) or hospitals. These policies are effective beginning March 31, 2020, and will remain in effect for the duration of the public health emergency, unless DEA specifies an earlier date. This decision tree merely summarizes the policies for quick reference and does not provide a complete description of all requirements.

03-31-2020

04-01-2020

Controlled Substance Prescriptions

COVID-19

No

COVID-19 Q&A Mail Methadone

DEA-DC-24

Methadone

DEA regulations prohibiting mail delivery of methadone to NTP patients remain in effect. DEA believes that the potential for diversion and abuse of methadone for MAT treatment of narcotic dependent persons is too high to permit NTPs to dispense via the Postal Service. To ensure continued access during the COVID-19 health emergency, DEA has authorized NTP employees, law enforcement and National Guard personnel to deliver methadone to patients who cannot travel to the NTP.

03-25-2020

04-07-2020

Other

COVID-19

No

COVID-19 QA EPCS Hospitals & Remote ID Proofing

DEA-DC-26

EPCS

During the COVID-19 public health emergency, DEA-registered hospitals/clinics may conduct remote identity proofing of individual practitioners to issue authentication credentials to eligible practitioners engaged in electronic prescribing of controlled substances, in conformance with existing regulations. DEA suggests using a device that allows for real-time, two-way, audio-visual interactive communication to do so.

04-08-2020

04-13-2020

Controlled Substance Prescriptions

COVID-19

No

COVID-19 SAMHSA Telemedicine (Phone)

DEA-DC-22

Telemedicine

In light of the nationwide public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020, as a result of the Coronavirus Disease (COVID-19), and only for the duration of this public health emergency (unless DEA specifies an earlier date), OTPs should feel free to dispense, and DATA-waived practitioners should feel free to prescribe, buprenorphine to new patients with OUD for maintenance treatment or detoxification treatment following an evaluation via telephone voice calls, without first performing an in-person or telemedicine evaluation. This may only be done, however, if the evaluating practitioner determines that an adequate evaluation of the patient can be accomplished via the use of a telephone. The prescription also must otherwise be consistent with the practitioner’s aforementioned obligation under the CSA and DEA regulations to only prescribe controlled substances for a legitimate medical purpose while acting in the usual course of professional practice.

03-31-2020

03-31-2020

Other

COVID-19

No

Civil Unrest Q&A Registration of New Building at Same Address (Pharmacy)

DEA-DC-031

Registration - Civil Unrest

Questions and answer concerning obtaining a new DEA registration number for a temporary pharmacy that is replacing a damaged pharmacy due to civil unrest/looting at the same physical address.

This document identified a DEA regulation that may create unintended consequences for a formerly incarcerated individual that is attempting to successfully reenter society. Specifically, 21 CFR 1301.90 has been identified as such because this regulation sets forth specific questions in order for a non-practitioner to comprehensively screen employees. It also states DEA’s position on employee screening by non-practitioners in which “….obtaining information by non-practitioners is vital to fairly assess the likelihood of an employee committing a drug security breach. In this regard, it is believed that conviction of crimes and unauthorized use of controlled substances are activities that are properly subjects for injury.” Although 21 CFR 1301.90 has been identified, DEA would like to clarify that such regulation is only applicable to screening procedures for prospective employees at a non-practitioner DEA registered location where controlled substances are stored, distributed, manufactured, or otherwise handled and not applicable to prospective employees who will be employed at non-registered locations (ie corporate headquarters or sales offices).

DEA’s policy concerning Locum Tenens provides an exception to 21 CFR 1301.12(a) requiring separate registration for each place of practice where controlled substances are handled. Separate registrations are not required in locations within the same state where practitioners merely prescribe. If practicing in multiple states, a practitioner at a hospital can use a hospital’s registration, and/or transfer an existing registration from one state to another through DEA’s Registration Section.

09-13-2010

01-29-2020

Other

Locum Tenens

No

Drug Addiction in Health Care Professionals

DEA-DC-1

Drug Addiction

This informational pamphlet is aimed at health care professionals. It is a guide to show how they can recognize drug addiction with co-workers and/or a drug impaired co-workers. The information alerts the reader to certain signs, behaviors or symptoms that the drug impaired co-worker may exhibit. The material discusses things such as absenteeism, frequent disappearances, not meeting deadlines and work performances alternating between low and high periods of productivity. The material also identifies responsibilities and things that can be done to help the co-worker. The guide also provides signs that an individual maybe diverting controlled substances.

01-29-2020

Other

Pamphlet

No

Emergency CII Call In Exception

DEA-DC-21

Prescriptions

This is a guidance letter clarifying the circumstances under which oral schedule II prescriptions are permitted and provides temporary exceptions due to the Public Health Emergency declared by the Secretary of Health and Human Services. The Controlled Substances Act, 21 U.S.C. 801 et seq., provides that a pharmacist may not dispense a schedule II controlled substance without a written prescription with the exception of an oral prescription in emergency situations. According to 21 CFR 1603.11(d), to issue an emergency oral prescription, the quantity prescribed and dispense is to be limited to the amount adequate for treatment of the patient during the emergency period; prescription shall be immediately reduced to writing by pharmacist and contain all information required in 1306.05, except for prescribing practitioner’s signature; if pharmacist does not know the individual prescribing practitioner, the pharmacist must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner; and within 7 days after authorizing an emergency oral prescription, the individual prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to be delivered to the dispensing pharmacist. In addition to the exception stated above, DEA announces two temporary exceptions: (1) practitioners have 15 days to deliver the follow-up paper prescription to the dispensing pharmacy; and (2) practitioners are allowed to send the follow-up prescription via facsimile, photograph, or scan to the pharmacy in place of the paper prescription. The practitioner must ensure that for whichever method they use, the prescription contains all required information stated in 1306.05 and 1306.11(d), including a statement that prescription is “Authorized for Emergency Dispensing.” Practitioners who choose to send this specific type of prescription to the pharmacy via facsimile, photograph, or scan must maintain the original paper prescription in the patient file. There is no numerical limit to the amount of schedule II controlled substance to be prescribed.

03-27-2020

03-30-2020

Controlled Substance Prescriptions

COVID-19

No

Faxing DEA Form 222s - COVID-19

DEA-DC-19

Records and Reports

In light of the current public health crisis declared by the Secretary of HHS on January 31, 2020, as a result of Coronavirus Disease 2019 (COVID-19) and the determination by WHO on March 11, 2020 that the global COVID-19 outbreak constitutes a pandemic, DEA will grant an exception to 21 CFR 1305.13 regarding the requirement that a purchaser mail a hard copy version of DEA Form 222 to the original supplier in order to ensure an adequate supply of controlled substances for the duration of this public health emergency. Normally, under the CSA, the distribution of a schedule I or II controlled substance must be pursuant to an order form that complies with the DEA regulations. The DEA regulations provide that either a DEA Form 222 or its electronic equivalent is required for each distribution of a schedule I or II controlled substance. 21 CFR 1305.03. A purchaser of a schedule I or II controlled substance that utilizes a paper copy must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier. 21 CFR 1305.13(a). Under this exception, all DEA registrants who order controlled substances are permitted to fax or scan/email a DEA Form 222 to their respective suppliers. This exception is granted from March 20, 2020 through the duration of this public health emergency as declared by the Secretary of HHS.

03-25-2020

03-26-2020

Records and Reports

COVID-19

No

National Health Emergency and Telemedicine - COVID-19

DEA-DC-16

Telemedicine - COVID-19

On January 31, 2020, Department of Health and Human Services Secretary Azar declared a public health emergency due to the COVID-19 virus. This documents answers DEA registrants questions concerning the practice of telemedicine during this national health emergency.

03-17-2020

03-18-2020

Other

Telemedicine

No

Pharmacist Guide to Prescription Fraud

DEA-DC-2

Pharmacist Guide

This information alerts the reader to certain signs, behaviors or symptoms that the drug impaired co-worker may exhibit. The material discusses things such as absenteeism, frequent disappearances, not meeting deadlines and work performances alternating between low and high periods of productivity. The material also gives the reader what are his/her responsibilities and things they can do to help to co-worker. The guide also provides signs that an individual maybe diverting controlled substances.

01-29-2020

Controlled Substance Prescriptions

Guide

No

Prescription Refills - COVID-19

DEA-DC-17

Prescription Refills - COVID-19

On March 21, 2020, the Drug Enforcement Administration issued guidance concerning the refill of schedule II through V controlled substances during the COVID-19 national health emergency.

03-21-2020

03-21-2020

Controlled Substance Prescriptions

COVID-19

No

Preventing Diversion

DEA-DC-13

Preventing Diversion

The document discusses ways for practitioners to be aware of signs that patients are trying to access drugs for diversion, such as giving vague symptoms, exaggerating pain, or avoiding tests and accessing medical history. The document also discusses ways for practitioners to avoid giving out prescriptions that could lead to diversion. Practitioners must assure they conduct medical examinations and tests while also looking out for signs of abuse when dealing with patients.

01-29-2020

Other

Pamphlet

No

Preventing the Retail Diversion of Pseudoephedrine

DEA-DC-4

Pseudoephedrine Diversion

Summary of the Combat Methamphetamine Epidemic Act of 2005 (CMEA). Preventing the Retail Diversion of Pseudoephedrine, including CMEA requirements, methamphetamine background information, and DEA’s goals in combating the methamphetamine epidemic.

01-29-2020

Other

Pamphlet

No

Questions and Answers for Pharmacies (EPCS)

DEA-DC-10

Pharmacies and EPCS

Questions and answers for pharmacies intended to summarize and provide general information regarding DEA’s Interim Final Rule for ECPS with request for comment. The topics discussed include, but are not limited to: Audits and Certification of Applications, Reporting Security Incidents, Records, and Transmission of Prescriptions to Pharmacies.

03-31-2010

01-29-2020

Controlled Substance Prescriptions

EPCS

No

Questions and Answers for Prescribing Practitioners (EPCS)

DEA-DC-9

Prescribing Practitioners

All records for prescribing of an FDA-approved narcotic for the treatment of opioid addiction need to be kept in accordance with 21 CFR 1304.03(c), 21 CFR 1304.21(b).

03-31-2020

01-29-2020

Controlled Substance Prescriptions

Q&A

No

Questions and Answers for Providers of Electronic Prescription Applications, Pharmacy Applications, and Intermediaries

This pamphlet is directed to medical practitioners to assist them in recognizing a drug abuser, give them actions to take when confronted by a suspected drug abuser, and responsibilities regarding proper prescribing to prevent diversion. This includes common characteristics of the drug abuser and modus operandi often used by a drug-abusing patient.

01-29-2020

Other

Pamphlet

No

SAMHSA NTP Deliveries Exception

DEA-DC-15

NTP - COVID-19

On January 31, 2020 the Secretary of HHS declared a public health emergency, and asked for DEA-registered narcotic treatment programs (NTPs) to have an exception to 21 CFR 1301.74(i) in order to provide consistent dosing to patients enrolled in NTPs. The Secretary of HHS also asked that in the event a patient is quarantined due to the coronavirus, that an alternative delivery method using the NTP's established chain of custody protocol for take-home medications be allowed. Specifically, it was asked that the NTP make a “doorstep” deliver of take-home medication in an approved lock-box, by an authorized NTP staff member, law enforcement officer, or national guard personnel instead of limiting the person who are allowed to deliver specified in 21 CFR 1301.74(i). DEA reviewed the request for an exception to 21 CFR 1301.74(i), and took into account the safeguards against diversion incorporated into the guidance for Opioid Treatment Programs, and granted the exception to 21 CFR 11301.74(i), but only to the extent that such activities will take place during the HHS-declared public health emergency.

03-16-2020

03-16-2020

Other

NTP

No

Separate Registration In Each State (Reciprocity)

DEA-DC-18

Registration - COVID-19

On account of the COVID-19 public health emergency declared by the Department of Health and Human Services on January 31, 2020, the DEA is granting a temporary exception to the requirement that a practitioner be registered in each state where they dispense controlled substances. Dispensing traditionally refers to both the state of practitioner’s licensing/practice, and the state in which the patient is located. However, under this temporary exception, practitioners may dispense controlled substances (including dispensing via telemedicine) in states where they do not hold a registration - provided that they still hold at least one registration, and comply with all applicable state laws.

03-25-2020

03-25-2020

Registration

COVID-19

No

Use of Mobile Devices in the Issuance of EPCS

DEA-DC-8

Mobile Devices and EPCS

The remote practitioner engaged in the practice of telemedicine must be registered with DEA in the State where they are physically located and in every State where their patient(s) is (are) physically located.

08-16-2018

01-29-2020

Controlled Substance Prescriptions

EPCS

No

Use of Telemedicine While Providing Medication Assisted Treatment (MAT)

DEA-DC-7

Telemedicine and Medication Assisted Treatment

The Ryan Haight Act requires that practitioners prescribing by means of the Internet conduct at least one in-person medical evaluation of their patient. (21 USC. 829(e)). However, there is an exception to this requirement; if the practitioner is DEA-registered and acting within the U.S, they can be exempt from the in-person medical evaluation if the practitioner is engaged in the practice of telemedicine and in accordance with 21 USC 802(54). The remote practitioner engaged in the practice of telemedicine must be registered with DEA in the State where they are physically located and in every State where their patient(s) is (are) physically located. All records for prescribing of an FDA-approved narcotic for the treatment of opioid addiction need to be kept in accordance with 21 CFR 1304.03(c), 21 CFR 1304.21(b).

05-05-2018

01-29-2020

Other

Telemedicine

No

Veterinary Medicine Mobility Act of 2014

DEA-DC-14

Veterinary Medicine Mobility Act of 2014

The DEA policy letter from Louis J. Milione to registrant explaining that the Veterinary Mobility Act of 2014 should be interpreted exactly as written, and outlines the situations that vets can transport and dispense CS a site other than their principle place of business without a separate registration according to the new law. “House calls” are used as the prime example in which the vet does not need a separate registration to dispense CS.